The development of laboratory developed tests (LDTs) and in vitro diagnostics (IVDs) requires the execution of studies to determine the analytical performance of the assay. Examples of analytical studies include limit of detection, intermediate …
Supporting data-driven decisions in the planning of clinical trials during the current pandemic involves extensive integration of heterogenous data sources, sophisticated predictive modelling, and custom visualization to communicate the predictions …
In this workshop we will walk through an implementation of the R Validation Hub's white paper A Risk-based Approach for Assessing R Package Accuracy within a Validated Infrastructure (https//www.pharmar.org/white-paper/). The workshop will explore …
In the early phases of clinical development, the future of a compound depends on more than just the result of hypothesis test on a single endpoint, in a single phase 2 study. We think a lot about how design choices affect immediate outcomes. GSK's …
GlaxoSmithKline is searching for new oncology drug targets. We have CRISPR knockout data for many cancer cell lines and many genes. For these same cell lines, we also have genomic data --somatic mutations, copy number variants, and gene expression. …
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The first challenge in validating an analytic tool for the pharmaceutical industry is that, despite a formal FDA definition, there is still no cross-industry agreement on what 'validation' really means with respect to an analytic tool. AIMS …